New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

04/09/2009

Trade Name:

Ulesfia Lotion, 5%

Generic Name or Proper Name (*):

benzyl alcohol

Indications Studied:

Treatment of head lice

Label Changes Summary:

* Safety and effectiveness established in pediatric patients 6 months and older * Safety in pediatric patients < 6 months has not been established. * Not recommended in pediatric patients < 6 months due to potential for increased systemic absorption * Neonates are at risk of gasping syndrome due to benzyl alcohol * Adverse events similar to those observed in adults * Information on dosing and administration, warnings and precautions, adverse events, PK parameters, and clinical studies * New drug